APPLICATION
ANDA085998
TYPE
ANDA
ORIGINAL APPROVAL
1978-08-16
LATEST ACTION
2002-07-08
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
HYDROXOCOBALAMINPrescription
HYDROXOCOBALAMIN 1MG/ML · INJECTABLE · INJECTION
Approval history
2002-07-08Manufacturing (CMC) · Supplement 91AP
2002-06-06Manufacturing (CMC) · Supplement 89AP
2002-02-12Manufacturing (CMC) · Supplement 86AP
2001-07-18Manufacturing (CMC) · Supplement 90AP
2001-05-04Manufacturing (CMC) · Supplement 88AP
2001-05-04Manufacturing (CMC) · Supplement 87AP
2000-09-15Manufacturing (CMC) · Supplement 85AP
2000-08-18Manufacturing (CMC) · Supplement 83AP
2000-06-29Manufacturing (CMC) · Supplement 84AP
2000-05-25Manufacturing (CMC) · Supplement 81AP
1999-11-22Labeling · Supplement 80AP
1999-11-22Manufacturing (CMC) · Supplement 79AP
1999-03-04Manufacturing (CMC) · Supplement 76AP
1999-02-19Manufacturing (CMC) · Supplement 77AP
1999-02-02Manufacturing (CMC) · Supplement 75AP
1997-10-29Labeling · Supplement 74AP
1997-10-29Manufacturing (CMC) · Supplement 72AP
1996-12-04Manufacturing (CMC) · Supplement 73AP
1992-02-11Labeling · Supplement 71AP
1992-02-11Labeling · Supplement 107AP
1989-05-09Manufacturing (CMC) · Supplement 70AP
1989-05-09Manufacturing (CMC) · Supplement 69AP
1986-08-07Manufacturing (CMC) · Supplement 66AP
1978-08-16OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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